Increasing Patching for Amblyopia in Children 3 to < 8 Years Old (ATS15)

This study has been completed.

Sponsor:

Jaeb Center for Health Research

ClinicalTrials.gov Identifier:

NCT00945100

First Posted: July 23, 2009

Last Update Posted: July 13, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Between September 2009 and December 2012, 45 sites randomized 169 participants to either increase patching time to an average of 6 hours per day (n=86) or continue 2 hours daily patching (n=83).

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Prior to being considered for the randomized trial, participants who had not already completed at least 12 weeks of 2 hours of daily patching were enrolled into a run-in phase and treated with 2 hours of daily patching (and spectacles if needed) with follow-up every 6 weeks until no improvement.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Control

2 hours daily patching

Intensified Treatment

42 hours per week of patching (averaging 6 hours daily)

Total

Total of all reporting groups

Baseline Measures

Control

Intensified Treatment

Total

Overall Participants Analyzed [Units: Participants]

83

86

169

Age [Units: Participants]

<=18 years

83

86

169

Between 18 and 65 years

0

0

0

>=65 years

0

0

0

Age [Units: Years]Mean (Standard Deviation)

5.9 (1.3)

5.9 (1.2)

5.9 (1.3)

Age, Customized [1] [Units: Participants]

3 to <4 years

5

8

13

4 to <5 years

15

15

30

5 to <6 years

27

19

46

6 to <7 years

17

25

42

7 to 8 years

19

19

38

[1]

Baseline age reflects age at randomization.

The age eligibility requirement at enrollment was 3 to <8 years old, however, there were 7 participants who were enrolled into the run-in phase that were 8 years old by the time they were randomized.

Gender [Units: Participants]

Female

43

43

86

Male

40

43

83

Race/Ethnicity, Customized [Units: Participants]

White

57

66

123

Black/African American

8

2

10

Hispanic

14

14

28

Asian

2

3

5

More than one race

2

1

3

Region of Enrollment [Units: Participants]

United States

80

82

162

United Kingdom

3

3

6

Canada

0

1

1

Enrollment Disposition [1] [Units: Participants]

No current treatment

48

49

97

On treatment

18

18

36

Ready for randomization

17

19

36

[1]

Participants were classified into 3 groups (no current treatment, on treatment, ready for randomization) according to their treatment disposition at enrollment.

Amblyopia associated with strabismus (comitant or incomitant), anisometropia, or both:

Criteria for strabismus: At least one of the following:

Heterotropia at distance and/or near fixation on examination (with or without spectacles)

History of strabismus surgery

Documented history which is no longer present (which in the judgement of the investigator could have caused amblyopia)

Criteria for anisometropia: At least one of the following:

At least 0.50 D difference between eyes in spherical equivalent

At least 1.50 D different between eyes in astigmatism in any meridian

Best distance visual acuity in the amblyopic eye at randomization [1] [Units: Participants]

20/160

2

3

5

20/125

3

1

4

20/100

2

7

9

20/80

6

6

12

20/63

17

21

38

20/50

26

24

50

20/40

21

18

39

20/32

6

6

12

[1]

Visual acuity was measured without cycloplegia using the participant's optimal spectacle correction (if applicable) by a study-certified tester using the ATS-HOTV protocol on the Electronic Visual Acuity Tester.

Best amblyopic eye visual acuity was computed as the better of the initial test and retest visual acuities at randomization.

Visual acuity was measured without cycloplegia using the participant's optimal spectacle correction (if applicable) by a study-certified tester using the ATS-HOTV protocol on the Electronic Visual Acuity Tester.

Best amblyopic eye visual acuity was computed as the better of the initial test and retest visual acuities at randomization.

Best distance visual acuity in the fellow eye at randomization [1] [Units: Participants]

20/32

5

5

10

20/25

17

21

38

20/20

27

26

53

20/16

34

34

68

[1]

Visual acuity was measured without cycloplegia using the participant's optimal spectacle correction (if applicable) by a study-certified tester using the ATS-HOTV protocol on the Electronic Visual Acuity Tester.

Best fellow eye visual acuity was computed as the better of the initial test and retest visual acuities at randomization.

Visual acuity was measured without cycloplegia using the participant's optimal spectacle correction (if applicable) by a study-certified tester using the ATS-HOTV protocol on the Electronic Visual Acuity Tester.

Best fellow eye visual acuity was computed as the better of the initial test and retest visual acuities at randomization.

Treatment Group Comparison of the Proportion of Participants Who Have Improved by 2 or More logMAR Visual Acuity Lines Based on Visual Acuity at Best Post-randomization Visit [ Time Frame: 10 weeks after randomization or later ]

Mean Change in Best Fellow Eye Visual Acuity Since Randomization at 10 Weeks

Measure Description

No text entered.

Time Frame

10 weeks after randomization

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The analysis includes data from participants who completed a 10-week exam.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

A potential study limitation is that compliance with patching was based on discussions with the parent and by reviewing study calendars maintained by the parent, which not an objective measure of compliance.